COPD Clinical Trial
Official title:
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
NCT number | NCT01495780 |
Other study ID # | eRT RHM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2012 |
Est. completion date | August 20, 2014 |
Verified date | April 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor
visits, using things like at-home breathing tests, electronic diaries to answer
questionnaires, and other monitoring devices. The hypothesis of this study is that the health
and quality of life of people with COPD who do RHM for one year will be better than people
with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with
chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema,
and are current or former smokers will be invited to participate. This study is paid for by
eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will
participate in RHM. RHM will involve daily monitoring at home using a few electronic devices:
blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring.
Visits will include physical exam and medical history, ECG, questionnaires, breathing tests,
and exercise tests.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 20, 2014 |
Est. primary completion date | August 20, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Age >40 years. - Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9 - Smoking history >10 pack-years. - Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values - Domestic situation felt to be supportive of remote health monitoring. - Ability to give informed consent. Exclusion Criteria: - Clinical diagnosis of asthma. - Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction. - Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke). - Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit. - Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial. - Myocardial infarction within 6 weeks of enrolment. - Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day. - A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA David Geffen School of Medicine | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | eResearch Technology (eRT) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance with daily RHM | Compliance with daily RHM as a percentage of study days | 1 year | |
Primary | Integrity of spirometric data | Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability. | 1 year | |
Secondary | Rate of adoption of RHM | Time it takes for subjects to become compliant with daily RHM | 1 year | |
Secondary | Treatment adherence | Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician) | 1 year | |
Secondary | Time to first COPD exacerbation | Time to first COPD exacerbation as defined by standard criteria. | 1 year | |
Secondary | Number of COPD exacerbations per year | 1 year | ||
Secondary | Proportion of subjects experiencing one or more exacerbations | 1 year | ||
Secondary | Mean daily FEV1 | 1 year | ||
Secondary | Mean daily IC | 1 year | ||
Secondary | Mean daily activity level | 1 year | ||
Secondary | Mean daily SpO2 | 1 year | ||
Secondary | Daily symptom scores | 1 year | ||
Secondary | Number of physician visits | 1 year | ||
Secondary | Number of emergency department visits | 1 year | ||
Secondary | Number of hospitalizations | 1 year | ||
Secondary | Number of days spent in hospital | 1 year | ||
Secondary | Health care costs | Inferred health care costs using a standard cost framework model | 1 year |
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